Suture anchor with relief mechanism

ABSTRACT

Methods and devices are provided for attaching soft tissue to bone. In general, a deployment device, insertion assembly, and suture anchor are provided. The insertion assembly is coupled between the deployment device and the suture anchor to allow the deployment device to deploy the suture anchor into bone. Each of the various components disclosed herein can be used alone, in combination with one another, or in combination with various other devices.

FIELD OF THE INVENTION

This invention relates generally to medical devices and procedures. Moreparticularly, this invention relates to systems and methods forattaching soft tissue to bone.

BACKGROUND OF THE INVENTION

The complete or partial detachment of ligaments, tendons and/or othersoft tissues from their associated bones within the body are relativelycommonplace injuries, particularly among athletes. Such injuries aregenerally the result of excessive stresses being placed on thesetissues. By way of example, tissue detachment may occur as the result ofan accident such as a fall, over-exertion during a work-relatedactivity, during the course of an athletic event, or in any one of manyother situations and/or activities.

In the case of a partial detachment, the injury will frequently healitself, if given sufficient time and if care is taken not to expose theinjury to further undue stress. In the case of complete detachment,however, surgery may be needed to re-attach the soft tissue to itsassociated bone or bones. Numerous devices are currently available tore-attach soft tissue to bone. Examples of such currently-availabledevices include screws, staples, suture anchors and tacks. In softtissue re-attachment procedures utilizing screws, the detached softtissue is typically moved back into its original position over the bone.Then the screw is screwed through the soft tissue and into the bone,with the shank and head of the screw holding the soft tissue to thebone. Similarly, in soft tissue re-attachment procedures utilizingstaples, the detached soft tissue is typically moved back into itsoriginal position over the bone. Then the staple is driven through thesoft tissue and into the bone, with the legs and bridge of the stapleholding the soft tissue to the bone.

In soft tissue re-attachment procedures utilizing suture anchors, ananchor-receiving hole is generally first drilled in the bone at thedesired point of tissue re-attachment. Then a suture anchor is deployedin the hole using an appropriate installation tool. This effectivelylocks the suture to the bone, with the free end(s) of the sutureextending out of the bone. Next, the soft tissue is moved into positionover the hole containing the deployed suture anchor. As this is done,the free end(s) of the suture is (are) passed through or around the softtissue, so that the free end(s) of the suture reside(s) on the far(i.e., non-bone) side of the soft tissue. Finally, the suture is used totie the soft tissue securely to the bone.

Alternatively, in some soft tissue re-attachment procedures utilizingsuture anchors of the type described above, the soft tissue may first bemoved into position over the bone. Then, while the soft tissue lies inposition against the bone, a single hole may be drilled through the softtissue and into the bone. Next, a suture anchor is passed through thesoft tissue and deployed in the bone using an appropriate installationtool. This results in the suture anchor being locked to the bone, withthe free end(s) of the suture extending out of the bone and through thesoft tissue. Finally, the suture is used to tie the soft tissue securelyto the bone. In some cases, the suture anchor may include drill means atits distal end, whereby the suture anchor can be drilled into the bone,or drilled through the soft tissue and into the bone, whereby theaforementioned drilling and anchor-deployment steps are effectivelycombined.

Similarly, in soft tissue re-attachment procedures utilizing tacks, thedetached soft tissue is typically moved back into its original positionover the bone, and then a tack-receiving hole is generally drilledthrough the soft tissue and into the bone. Then the tack is driventhrough the soft tissue and into the bone, so that the shaft and head ofthe tack will hold the soft tissue to the bone.

While systems and method based on the aforementioned screws, staples,suture anchors and tacks are generally effective, they also all sufferfrom one or more disadvantages. Accordingly, there remains a need forimproved methods and devices for attaching soft tissue to bone.

SUMMARY OF THE INVENTION

The present invention provides various methods and device for attachingsoft tissue to bone. In one embodiment, an anchor insertion device isprovided and includes a housing having an outer shaft extending distallytherefrom and configured to receive an anchor insertion assembly, and asuture retaining element formed on the housing and configured to retaina suture coupled to a suture anchor mated to a distal end of an anchorinsertion assembly. A handle assembly is slidably coupled to the housingand it is configured to engage an anchor insertion assembly disposedthrough the outer shaft and the housing such that the handle assemblyand anchor insertion assembly are slidably movable relative to thehousing and outer shaft to thereby deploy a suture anchor coupled to adistal end of the anchor insertion assembly.

The handle assembly can have various configurations, but in oneembodiment it can include a trigger pivotally coupled thereto andconfigured to pivot to slidably move the handle assembly relative to thehousing. A gear mechanism can be disposed within the handle assemblysuch that pivotal movement of the trigger is effective to actuate thegear mechanism to slidably move the handle assembly relative to thehousing. In an exemplary embodiment, the gear mechanism is adapted toslidably move the handle assembly in a proximal direction relative tothe housing.

The suture retaining element can also have a variety of configurations,but in one embodiment it can include a suture tensioning assemblyadapted to tension a suture extending between a suture anchor and thesuture tensioning assembly. The suture tensioning assembly can include,for example, a wheel rotatably coupled to the housing and a ratchetmechanism for allowing rotation of the wheel in a fixed direction toallow suture disposed there around to be tensioned, and for preventingrotation of the wheel in a second, opposite direction. The device canalso include a lever coupled to the suture tensioning assembly andconfigured to release the ratchet mechanism to allow free rotation ofthe wheel in the second, opposite direction.

In another embodiment, a suture anchor assembly is provided and includesa suture anchor having an insert with a suture mated thereto, and asleeve disposable over the insert and configured to lock the suturebetween the insert and the sleeve. The suture anchor assembly can alsoinclude a deployment device having a housing with a suture tensioningelement mated to the suture for tensioning the suture between the insertand the suture tensioning element, and an actuation mechanism movablycoupled to the housing and having a distal end mated to the sleeve suchthat the actuation mechanism is configured to position the sleeve overthe insert while the suture remains fixed between the tensioning elementand the insert. The suture anchor assembly can also include an insertershaft extending through the housing and having a proximal end coupled tothe actuation mechanism and a distal end coupled to the sleeve. Incertain exemplary embodiments, the inserter shaft can extend through anouter shaft extending distally from the housing. The suture anchorassembly can also include a pusher slidably disposed around the insertershaft and located between a distal end of the outer shaft and a proximalend of the insert. In other embodiments, the actuation mechanism can beslidably movable relative to the housing such that the actuationmechanism and anchor insertion assembly slide relative to the housingand outer shaft to position the sleeve over the insert. The actuationmechanism can be, for example, a handle assembly having a triggerpivotally coupled thereto such that pivoting movement of the trigger iseffective to move the handle assembly relative to the housing.

Exemplary methods for deploying a suture anchor are also provided. Inone embodiment, the method can include inserting a suture anchor coupledto a distal end of a deployment device into bone, coupling suturebetween an inner component of the suture anchor and a suture retainingelement located on a housing of the deployment device, and actuating ahandle assembly to position an outer component of the suture anchor overthe inner component of the suture anchor thereby locking the suturebetween the inner and outer components. The housing and inner componentcan remain in a substantially fixed position relative to one another asthe handle assembly is actuated such that tension applied to the sutureextending between the inner component and the housing remainssubstantially fixed. In certain exemplary embodiments, the handleassembly can slide proximally relative to the housing when the handleassembly is actuated. Actuating the handle assembly can include pivotinga trigger coupled to the handle assembly. In another embodiment, thesuture retaining element can be a suture tensioning assembly, and themethod can include actuating the suture tensioning assembly to tensionthe suture between the suture tensioning assembly and the innercomponent of the suture anchor.

In other aspects, a method for deploying a suture anchor is provided andincludes inserting a suture anchor coupled to a distal end of adeployment device into bone, tensioning a suture coupled to a firstcomponent of the suture anchor, and actuating a handle assembly to slidethe handle assembly relative to the housing of the deployment device,thereby mating a second component of the suture anchor with the firstcomponent of the suture anchor to lock the suture between the first andsecond components. In one exemplary embodiment, the second component ispulled over the first component when the handle assembly is actuated. Inanother embodiment, tensioning the suture can include coupling thesuture between the first component of the suture anchor and a sutureretaining element located on a housing of the deployment device. Inother aspects, the suture retaining element, first component, and suturecan remain in a substantially fixed position as the handle assembly isslid relative to the housing. In yet another embodiment, the sutureretaining element can be, for example, a suture tensioning assembly andthe method can include tensioning the suture between the first componentof the suture anchor and the suture tensioning assembly.

The present invention also provides various suture anchor devices. Inone embodiment, a suture anchor device is provided having an insert witha sidewall extending between leading and trailing ends and defining aninner lumen extending through the insert, and at least one bore formedin the sidewall and configured to receive a suture therethrough. Thesuture anchor device also includes an outer sleeve disposable over theinsert and configured to lock a suture between the outer sleeve and theinsert. The insert and the outer sleeve can include a snap-lockengagement mechanism formed there between for locking the insert and theouter sleeve together.

While various snap-lock engaging mechanism can be used, in oneembodiment the device can include at least one pin formed on at leastone of the insert and the outer sleeve, and at least one complementarybore formed in the other one of the insert and the outer sleeve. Thedevice can also include other features, such as an alignment mechanismformed between the insert and the outer sleeve and configured torotationally align the insert and the outer sleeve during insertion ofthe outer sleeve over the insert. The alignment mechanism can be, forexample, at least one protrusion formed on at least one of the insertand the outer sleeve, and at least one complementary detent formed inthe other one of the insert and the outer sleeve. In another embodiment,the insert can include a plurality of detents formed adjacent to theleading end of the insert, and the outer sleeve can include a pluralityof protrusions formed adjacent to a trailing end of the outer sleeve andconfigured to sit within the plurality of detents formed on the insertfor rotationally aligning the insert and outer sleeve. The trailing endof the insert can optionally be flared and it can be configured tofrictionally engage a trailing end of the outer sleeve. The trailing endof the insert can also optionally include a notch formed therein andconfigured to receive a corresponding protrusion formed on an insertershaft for rotationally aligning the insert with the inserter shaft. Inother embodiments, the insert and the outer sleeve can have a modulus ofelasticity that is substantially the same as one another.

In yet another embodiment, a suture anchor assembly is provided andincludes a hollow insert having at least one bore formed therein andconfigured to receive a suture therethrough, an outer sleeve disposableover the insert and configured to lock a suture between the outer sleeveand the insert, and an inserter shaft having a distal end extendingthrough the insert and removably mated to the outer sleeve. The insertershaft can include a pusher slidably disposed thereon and configured toabut against a proximal end of the insert to allow the pusher andinserter shaft to be moved relative to one another to position the outersleeve over the hollow. The proximal end of the insert and a distal endof the pusher can optionally include an alignment mechanism formed therebetween and configured to rotationally align the insert with the pusher.In another embodiment, the insert and the outer sleeve can include asnap-lock engagement mechanism formed there between for locking theinsert and the outer sleeve together. The snap-lock engaging mechanismcan be, for example, at least one pin formed on at least one of theinsert and the outer sleeve, and at least one complementary bore formedin the other one of the insert and the outer sleeve. The trailing end ofthe insert can also optionally be flared and configured to frictionallyengage a trailing end of the outer sleeve.

In another embodiment, a method for anchoring suture in bone is providedand includes inserting a suture anchor coupled to a distal end of aninserter shaft into bone such that a suture coupled to an insert of thesuture anchor extends from the bone, and moving the inserter shaft and apusher slidably disposed around the inserter shaft relative to oneanother to position a sleeve of the suture anchor around the insert tolock the suture there between. The insert and sleeve can lock togetherusing a snap-lock connection. Locking the insert and the sleeve caninclude positioning at least one protrusion formed on at least one ofthe insert and the sleeve within at least one corresponding bore formedin the other one of the insert and the sleeve to snap-lock the insertand sleeve together. In certain exemplary embodiments, the pusher ismaintained in a fixed position as the inserter shaft is retractedrelative to the pusher. Alternatively, the inserter shaft can bemaintained in a fixed position as the pusher is advanced relative to theinserter shaft.

The method can also include, prior to moving the inserter shaft andpusher, tensioning the suture extending from the bone. For example, thesuture can be tensioned by coupling the suture extending from the boneto a suture tensioning assembly to tension the suture between the suturetensioning assembly and the insert. The tension applied to the suturecan be maintained at a substantially fixed tension when the sleeve ispositioned over the insert.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of one embodiment of a suture anchordeployment device, insertion assembly, and a suture anchor;

FIG. 2 is a perspective view of the deployment device of FIG. 1;

FIG. 3 is a partially exploded view of the deployment device of FIG. 2,showing first and second portions that slidably move relative to oneanother;

FIG. 4 is a partially exploded perspective view of the deployment deviceof FIG. 2, showing a suture retaining element disposed therein;

FIG. 5 is an exploded perspective view of a portion of the deploymentdevice of FIG. 2;

FIG. 6A is a perspective view of another embodiment of a deploymentdevice;

FIG. 6B is a perspective view of a suture tensioning element of thedeployment device shown in FIG. 6A;

FIG. 6C is an exploded perspective view of the suture tensioning elementof FIG. 6B;

FIG. 7 is a partially exploded perspective view of a handle assembly ofthe deployment device of FIG. 2;

FIG. 8 is a cross-sectional view of the handle assembly of FIG. 7;

FIG. 9A is an exploded perspective view of a distal portion of aninsertion assembly of the deployment device of FIG. 2;

FIG. 9B is a perspective view of a pusher of the insertion assembly ofFIG. 9A;

FIG. 10 is a perspective view of the insertion assembly of FIG. 1 with asuture anchor about to be attached thereto;

FIG. 11 is a perspective view of the insertion assembly and sutureanchor of FIG. 10 fully assembled; and

FIG. 12 is an exploded view of the suture anchor shown in FIG. 1, havinga sleeve and an insert;

FIG. 13 is a perspective view of the sleeve of the suture anchor of FIG.12;

FIG. 14 is a cross-sectional view of the sleeve shown in FIG. 13;

FIG. 15 is a perspective view of the insert of the suture anchor of FIG.12;

FIG. 16 is a cross-sectional view of the insert shown in FIG. 15; and

FIG. 17 is a perspective view of the suture anchor deployment device,insertion assembly, and a suture anchor of FIG. 1 having a suturecoupled thereto and showing the device actuated to deploy the sutureanchor.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention generally provides methods and devices forattaching soft tissue to bone. In general, a deployment device,insertion assembly, and suture anchor are provided. The insertionassembly is coupled between the deployment device and the suture anchorto allow the deployment device to deploy the suture anchor into bone. Aperson skilled in the art will appreciate that each of the variouscomponents disclosed herein can be used alone, in combination with oneanother, or in combination with various other devices.

FIG. 1 generally illustrates one exemplary embodiment of a suture anchordeployment device 10 having an insertion assembly 100 coupled theretoand extending therefrom, and having a suture anchor 200 coupled to adistal end of the insertion assembly 100. The deployment device 10,which is shown in more detail in FIGS. 2 and 3, generally includes ahousing 20 having an outer shaft 22 extending distally therefrom forreceiving the insertion assembly 100, and a handle assembly 30 coupledto the housing 20 and configured to engage the insertion assembly 100.The handle assembly 30 and the insertion assembly 100 can move togetherrelative to the housing 20 and outer shaft 22 to deploy a suture anchor200 coupled to a distal end of the anchor insertion assembly 100. Whilethe type of movement between the housing 20 and the handle assembly 30can vary, in an exemplary embodiment the housing 20 and handle assembly30 are slidably movable relative to one another. FIG. 3 illustrates thehousing 20 and handle assembly 30 separated from one another. As shown,the handle assembly 30 can include one or more slots formed in asidewall thereof. FIG. 3 illustrates one slot 32 formed in the sidewallthereof, however a second slot can be formed in the opposed sidewall.The housing 20 can include one or more corresponding bores formedtherein and each bore can receive a pin configured to be slidablydisposed within a slot. FIG. 3 illustrates a bore 22 a formed in asidewall of the housing 20 and having a pin 22 b disposed therein. Thepin(s) and slot(s) will thus guide sliding movement between the housing20 and handle assembly 30 in proximal and distal directions. In anexemplary embodiment, actuation of the handle assembly 30 causes thehousing 20 to move in a proximal direction and/or the handle assembly 30to move in a distal direction.

Referring back to FIG. 1, the suture anchor 200 that is coupled to theinsertion assembly 100 generally includes an insert 210 and a sleeve 220that is disposable over the insert 210. The sleeve 220 is coupled to aninserter shaft 110 (FIG. 10) of the insertion assembly 100, and theinsert 210 is slidably disposed around the inserter shaft and it abutsagainst a pusher 120 positioned proximally adjacent thereto and alsoslidably disposed around the inserter shaft. The pusher 120 ispositioned just distal of the outer shaft 22 that extends distally fromthe housing 20.

As a result, actuation of the handle assembly 30 will cause the handleassembly 30 to move proximally, pulling the inserter shaft and sleeve220 proximally. The outer shaft 22 of the housing 20 will abut againstthe pusher 120 on the insertion assembly 100, and the pusher 120 in turnwill abut against the insert 210 to maintain the insert 210 in asubstantially fixed position while the sleeve 220 is being pulled thereover by the inserter shaft and handle assembly 30. Once the sleeve 220is disposed over the insert 210, a suture coupled to the anchor 200 willbe engaged between the sleeve 210 and insert 210. The suture can bemated to tissue, allowing the tissue to be anchored to bone within whichthe suture anchor 200 is disposed.

A person skilled in the art will appreciate that movement of the housing20 and handle assembly 30 is relative to each other, and that thedirection of movement of each component as described and claimed hereinis not intended to be limiting in any way. That is, the housing 20 canremained fixed while the handle assembly 30 moves, the handle assembly30 can remain fixed while the housing 20 moves, or both components canmove. The components that move can vary depending on the configurationof the suture anchor 200 and insertion assembly 100, as well as themethod of use.

The housing 20 of the deployment device 10, which is shown in FIGS. 2-5,can have a variety of configurations, but in the illustrated embodimentthe housing 20 generally includes first and second opposed housinghalves 20 a, 20 b (FIG. 4) that come together to define a generallyelongate, hollow body. The housing 20 can, however, be formed from asingle component, or from multiple components. An interior portion ofthe housing 20 can seat a portion of the handle assembly 30, which willbe discussed in more detail below. In an exemplary embodiment, thehousing 20 and handle assembly 30 are configured to slidably moverelative to one another in a proximal-distal direction, as previouslydescribed above. Thus, as shown in FIGS. 4 and 5, the proximal end 20 pof the housing 20 can include an opening 21 a formed therein forslidably receiving a proximal end 30 p of the handle assembly 30. Theopening 21 a can be formed by a cut-out formed in the proximal wall ofeach housing half 20 a, 20 b. The housing 20 can also include agenerally elongate, hollow outer shaft 22 that extends through anopening 21 b formed in a distal end 20 d of the housing 20. In anexemplary embodiment, the outer shaft 22 is fixedly coupled to thehousing 20 such that it moves in conjunction with the housing 20. Theparticular mating location can vary. In the embodiment shown in FIG. 4,the outer shaft 22 is configured to be fixedly captured between one ofthe housing halves, i.e., housing half 20 b, and a clamp member 24 whichis fastened to the housing half 20 b at a distal end 20 d of the housing20. This allows the outer shaft 22 to move with the housing 20 withoutinterfering with sliding movement of the handle assembly 30 relative tothe housing 20.

As further shown in FIG. 4, the outer shaft 22 can also extend through aportion of the handle assembly 30 to allow a gear assembly disposed inthe handle assembly 30 to engage the outer shaft 22 and slidably movethe outer shaft 22 and the housing 20 relative to the handle assembly30. The gear assembly and techniques for moving the outer shaft 22 andhousing 20 relative to the handle assembly 30 will be described in moredetail below with respect to FIGS. 7 and 8.

The deployment device 10 can also include a suture retaining elementformed or disposed thereon and configured to mate to a suture that iscoupled to a suture anchor being deployed. The suture retaining elementcan have a variety of configurations, and it can be in the form of aclamp, fastener, pin, or other element configured to receive and retaina suture. Regardless of the configuration, in an exemplary embodimentthe suture retaining element is configured such that tension applied toa suture extending between the suture retaining element and the sutureanchor will be maintained at a substantially fixed tension duringdeployment of the suture anchor. In the embodiment shown in FIGS. 4 and5, this is achieved by positioning a suture retaining element on thehousing 20. Since the suture extends between the insert of the sutureanchor and the suture retaining element, and since the insert moves withthe housing 20, the suture will move with the housing 20. As a result,the tension applied to the suture by the suture retaining element willbe maintained during deployment of the suture anchor, i.e., while thesleeve is being pulled over the insert. As indicated above, theparticular location of the suture retaining element can vary dependingon the configuration of the deployment device, insertion assembly, andsuture anchor. For example, the suture retaining element can be formedor disposed on the handle assembly 30 such that is moves in coordinationwith the handle assembly 30.

FIG. 5 illustrates one exemplary suture retaining element, in the formof a suture tensioning assembly 26. In general, the suture tensioningassembly 26 includes a tensioning wheel 27 that is effective to receivea suture there around such that rotation of the tensioning wheel 27increases or decreases tension applied to the suture. The illustratedtensioning wheel 27 is in the form a cylindrical housing 27 a having aknob 27 b formed on one end thereof for grasping and rotating thetensioning wheel 27, and having a central shaft 27 c extendingtherethrough. The central shaft 27 c is rotatably disposed through thehousing 20, and in particular through one of the housing halves, i.e.,housing half 20 b. As shown in FIG. 5, the device includes a bushing 12that sits within an opening 14 formed in the housing half 20 b, and thatrotatably seats a portion of the tensioning wheel 27. The bushing 12 ismated to the housing half 20 b using a spring clip 16 disposed therearound and positioned on an interior portion of the housing half 20 b.The suture tensioning assembly 26 can also include a mechanism formaintaining the tensioning wheel 27 in a desired rotated position. Asshown in FIG. 5, the tensioning assembly 26 includes a pawl and ratchetmechanism that is coupled to the shaft 27 c of the tensioning wheel 27.The ratchet mechanism is in the form of a wheel 28 a that is disposedaround the shaft 27 c and that includes teeth 28 b formed there around,and a pawl 29 a that rotatably mates to the housing half 20 b, e.g.,using a post 29 b formed on an interior of the housing half 20 b, andthat includes an arm 29 c that is configured to engage the teeth 28 bformed around the ratchet 28 a. In use, a length of suture can bewrapped around the tensioning wheel 27 to mate the suture to the wheel27. When the wheel 27 is rotated in a direction that applies tension tothe suture, i.e., further winds the suture around the wheel 27, the pawl29 a will engage the teeth 28 b on the ratchet 28 a to prevent the wheel27 from rotating in an opposite direction, thus maintaining the wheel 27in the desired rotated position and maintaining the tension on thesuture.

The suture tensioning assembly 26 can also include a mechanism torelease the tension applied to the suture, i.e., to release the pawl 29a from engagement with the teeth 28 b on the ratchet 28 a. In theembodiment shown in FIG. 5, the suture tensioning assembly 26 includes acam 23 that is disposed around the ratchet 28 a and that is configuredto cam the pawl 29 a out of engagement with the ratchet 28 a to allowfree rotation of the tensioning wheel 27. The cam 23 can include a lever23a formed thereon and extending through a portion of the housing 20 toallow the user to effect movement of the cam 23. Pivotal movement of thecam 23 relative to the housing 20 can release the pawl 29 a from theratchet 28 a. A person skilled in the art will appreciate that the camand ratchet mechanism can have a variety of other configurations.Moreover, various other suture tensioning or retaining elements can beused.

FIGS. 6A-6C illustrate another exemplary embodiment of a sutureretaining element. In general, FIG. 6A illustrates a deployment device10′ having a housing 20′ and a handle assembly 30′. In this embodiment,the suture retaining element 26′ is disposed on a back end of thehousing 20′, and it is configured to trap a suture, rather than have thesuture would there around. In particular, referring to FIGS. 6A and 6B,the components are similar to the previous embodiment however rotationof the cam 23′ causes a moving plate 24′ to slide toward a stationaryplate 25′ to trap a suture positioned there between. Once a suture istrapped, the tensioning wheel 27′ can be rotated to adjust the tensionapplied to the suture.

As previously indicated, the housing 20 can be slidably coupled to ahandle assembly 30 that is effective, upon actuation, to deploy a sutureanchor into bone. While the handle assembly 30 can have a variety ofconfigurations, in an exemplary embodiment, as shown in FIGS. 7 and 8,the handle assembly 30 generally includes a stationary member 32 and atrigger 34 movably coupled to the stationary member 32. In thisembodiment, the stationary member 32 is configured to engage an insertershaft 110 of the insertion assembly 100 (FIG. 10), and the trigger 34 isadapted to pivot toward the stationary member 32 to slide the housing 20relative to the handle assembly 30.

The stationary member 32 can have various shapes and sizes, but in oneembodiment, as shown, it has a generally elongate hollow, rectangularhousing portion 32 a and a stationary handle 32 b that extends from thehousing portion 32 a and that is configured to be grasped by a user. Thehousing portion 32 a is effective to receive and mate to the insertershaft 110 of the insertion assembly 100 (FIG. 10). In particular, thehousing portion 32 a can include an opening 33 formed in a distal end 32d thereof for receiving a proximal end of the inserter shaft. Thehousing portion 32 a can also include a mating element formed thereonfor removably engaging the inserter shaft. In the embodiment shown inFIGS. 7 and 8, the housing portion 32 a includes a locking member 36that is disposed through an opening 37 formed in a top surface of thehousing portion 32 a, and that includes a bore 36 b formed therethroughfor receiving the proximal end of the inserter shaft. The illustratedlocking member 36 is in the form of a generally square or rectangularshaped member, however the locking mechanism can have various othershapes and sizes. The locking member 36 can also be biased, e.g., usinga spring disposed within the housing portion 32 a, to a locked positionsuch that it will grasp and engage a notch formed in the proximal end ofthe inserter shaft to prevent the inserter shaft from being removed. Inorder to release the inserter shaft from the housing portion 32 a, thelocking member 36 can be depressed to overcome the biasing force,allowing free sliding movement of the inserter shaft relative thereto. Aperson skilled in the art will appreciate that a variety of othertechniques can be used to mate the inserter shaft to the housingportion.

As indicated above, the handle assembly 30 can also include a trigger 34that is movably coupled to the stationary portion 32a. While the type ofmovement of the trigger 34 can vary, in one embodiment the trigger 34 ispivotally coupled to the stationary portion 32 a such that it movesbetween an open position in which the trigger 34 is spaced apart fromthe stationary handle 32 b, as shown in FIG. 8, and a closed position inwhich the trigger 34 is positioned adjacent to the stationary handle 32b. In the illustrated embodiment, the trigger 34 is pivotally mated tothe stationary portion 32 a by a pivot pin 35. The trigger 34 can alsobe effective to engage the portion of the outer shaft 22 that extendsthrough the housing portion 32 a of the stationary member 32 such thatmovement of the trigger 34 between the open and closed positions iseffective to move the outer shaft 22 between proximal and distalpositions relative to the handle assembly 30. As a result, the housing20, which is coupled to the outer shaft 22, will move with the outershaft 22, thus allowing a suture anchor to be deployed, as will bediscussed in more detail below. While various techniques can be used toallow the trigger 34 to engage and slidably move the outer shaft 22within the housing portion 32 a of the handle assembly 30, in anexemplary embodiment the handle assembly 30 includes a gear mechanismdisposed therein. In the embodiment shown in FIGS. 7 and 8, the gearmechanism is in the form of a plurality of teeth 37 a formed on aterminal end 34 t of the trigger 34 and effective to engagecorresponding teeth 37 b formed on a proximal portion of the outer shaft22, as will be discussed below. As the trigger 34 pivots from the openposition to the closed position, the teeth 37 a on the trigger 34 willengage the teeth 37 b on the outer shaft 22 to move the outer shaft 22in a distal direction relative to the handle assembly 30. The housing 20(not shown) of the device 10 will thus move distally with the outershaft 22. Or, stated another way, the handle assembly 30 and theinserter shaft (not shown) coupled thereto will move in a proximaldirection relative to the housing 20 and outer shaft 22.

The trigger 34 can also be biased to the open position, such that aforce must be applied to the trigger 34 to overcome the biasing forceand move the trigger to the closed position, and such that release ofthe trigger 34 from the closed position will allow the trigger 34 toautomatically return to the open position. While various techniques canbe used to bias the trigger 34 to the open position, in one exemplaryembodiment, as shown in FIGS. 7 and 8, a spring 38 can be disposedbetween a proximal portion of the outer shaft 22 and a portion of thehousing portion 32 a of the stationary member 32 on the handle assembly30. In particular, the handle assembly 30 can include a hollow elongatemember or barrel 40 disposed therein and configured to slidably seat aproximal housing 42 formed on or disposed around a proximal portion ofthe outer shaft 22. The spring 38 can be disposed within the hollowbarrel 40, and a portion of the spring 38 can be positioned around aportion of the proximal housing 42 of the outer shaft 22. The teeth 37b, previously discussed above, can be formed on an inferior or bottomsurface of the proximal housing 42 on the outer shaft 22, and the teeth37 b can be positioned proximal of the spring 38. Thus, the spring 38will extend between the distal-most tooth of the proximal housing 42 ofthe outer shaft 22 and a distal end wall of the barrel 40, as shown inFIG. 8. The barrel 40 can also include an elongate slot or openingformed in an inferior or bottom surface thereof for receiving theterminal end 34 t of the trigger 34.

When the trigger 34 is moved from the open position to the closedposition, the proximal housing 42 on the outer shaft 22 will be moveddistally, thus compressing the spring 38 between the proximal housing 42and the distal end of the barrel 40. As a result, when the trigger 34 isreleased, the spring 38 will force the proximal housing 42 on the outershaft 22 back to the proximal position, thereby causing the teeth 37 bon the proximal housing 42 of the outer shaft 22 to engage the teeth 37a on the trigger 34 and pivot the trigger 34 back to the open position.As further shown in FIG. 7, the proximal housing 42 can also include aslot 42 a formed on a superior or top surface thereof for receiving apin 42 b extending through the housing portion 32a of the stationarymember 32 on the handle assembly 30. The pin 42 b and slot 42 a willallow the proximal housing 42 on the outer shaft 22 to slidably moveproximally and distally within the housing portion 32 a of thestationary member 32, while preventing rotation thereof to keep theteeth 37 b on the proximal housing 42 in alignment with the teeth 37 aon the trigger 34. A person skilled in the art will appreciate that avariety of other techniques can be used to bias the trigger 34 to anopen or a closed position, as may be desired.

The insertion assembly 100 is shown in more detail in FIGS. 9A-10. Asshown, the insertion assembly 100 generally includes an elongate shaft,referred to herein as an inserter shaft 110, and a pusher 120 disposedaround a portion of the inserter shaft 110. The inserter shaft 110includes a proximal end 110 a that is adapted to mate to the stationaryportion 32 of the handle assembly 30, as discussed above, and a distalend 110 b that is adapted to mate to one component of a suture anchor200, such as a sleeve 220 as will be discussed in more detail below.While various mating techniques can be used, in one embodiment thedistal end 110 b of the inserter shaft 110 can include threads 112formed around a portion thereof and adapted to engage correspondingthreads formed within the sleeve 220. The distal end 110 b can alsoinclude a pointed or sharpened tip 114 adapted to facilitate penetrationof the insertion assembly 100 into bone.

As indicated above, the inserter shaft 110 can also include a pusher 120disposed around a portion thereof. The pusher 120 can have variousconfigurations, but in an exemplary embodiment it is configured to bepositioned between a distal end 22 b (FIG. 8) of the outer shaft 22 ofthe deployment device 10 and a proximal end of an anchor, such as aproximal end of an insert 210 of anchor 200 as will be discussed below.The pusher 120 is also preferably slidably movable along a longitudinalaxis of the inserter shaft 110. This will allow the pusher 120 toadvance the insert 210 into the sleeve 220, or alternatively to maintainthe insert 210 in a fixed position as the sleeve 210 is pulledproximally there over. In other words, the insert 210, pusher 120, outershaft 22, and housing 20 will move in coordination with one anotherrelative to the sleeve 220, inserter shaft 110, and handle assembly 30to position the insert 210 within the sleeve 220.

As best shown in FIGS. 9A and 9B, in one exemplary embodiment the pusher120 can be in the form of an elongate, hollow tube that is slidablydisposed around a distal portion of the inserter shaft 110. An elongateslot or cut-out 121 can be formed in the pusher 120, and a pin 122 canbe disposed therethrough and mated to the inserter shaft 110 to allowslidable movement of the pusher 120 relative to the inserter shaft 110while preventing rotation of the pusher 120 around the inserter shaft110. Other techniques can optionally be used to slidably mate the pusher120 to the inserter shaft 110, or alternatively the pusher 120 canmerely float around the inserter shaft 110. When the pusher 120 is matedto the inserter shaft 110, as shown in FIGS. 10 and 11, the pusher 120will be positioned just proximal to the insert 210 such that the distalend 120 d of the pusher 120 abuts against the insert 210.

The pusher 120 can also optionally include an alignment mechanism forrotationally aligning the insert 210 with the pusher 120. This canfacilitate proper positioning of the insert 210 within the sleeve 220.While various alignment techniques can be used, in one exemplaryembodiment the pusher 120 and/or insert 210 can include a notch orprojection formed thereon and configured to be disposed within acorresponding notch or projection formed in the other one of the pusherand/or insert. For example, FIG. 9B illustrates a cut-out or notch 125and a projection 126 formed in the distal-most end of the pusher 120.The proximal-most end of the insert 210 can have a shape thatcomplements a shape of the distal-most end of the pusher 120, i.e., theinsert 210 can include a corresponding notch 215 and projection 216formed thereon, as shown in FIG. 16. The projection 216 on the insert210 can rest within the notch 125 in the pusher 120 to rotationallyalign the insert 210 with the pusher 120.

FIG. 11 illustrates the insertion assembly 100 fully assembled and matedto a suture anchor 200. While various suture anchors known in the artcan be used with the insertion assembly 100 and deployment device 10, inthe illustrated embodiment the suture anchor 200 generally includes anouter sleeve 220 that is adapted to be disposed within a bone tunnel,and an insert 210 that is adapted to be disposed within the outer sleeve220. The sleeve 220 and insert 210 are shown in more detail in FIGS.12-16. In general, the insert 210 can be configured to mate to a suturesuch that the suture will be locked between the insert 210 and outersleeve 220 when the insert 210 is disposed within the outer sleeve 220.The insert 210 can also be configured to cause at least a portion of theouter sleeve 220 to deformably expand to lock the outer sleeve 220within the bone tunnel.

Referring to FIGS. 13 and 14, the outer sleeve 220 of the suture anchor200 can have a generally elongate hollow configuration with a leadingdistal end 220 b and a proximal trailing end 220 a. The distal end 220 bcan have various shapes and sizes, and it can include a bone-penetratingtip formed thereon, or alternatively it can include a bore or opening221 formed therein as shown for allowing the tip of the inserter shaft110 (FIG. 10) to penetrate therethrough and guide the distal end 220 bof the sleeve 220 into a bone tunnel. As further shown in FIGS. 13 and14, the distal end 220 b can also be tapered to facilitate insertioninto a bone tunnel. The proximal portion of the sleeve 220 can also varyin shape and size, but in an exemplary embodiment the proximal portionhas a generally cylindrical shape for receiving the insert 210 therein.As further shown in FIG. 14, and as previously indicated, the sleeve 220can also include threads 222 formed therein for mating withcorresponding threads formed on the inserter shaft. While the locationof the threads 222 can vary, in the illustrated embodiment the threads222 are located just proximal to the tapered distal end 220 b of thesleeve 220. The sleeve 220 can also include other features that will bediscussed in more detail below.

The insert 210 is shown in more detail in FIGS. 15 and 16, and as shownthe insert 210 can have a generally elongate cylindrical configurationwith a distal leading end 210 b and a proximal trailing end 210 a. In anexemplary embodiment, at least a portion of the insert 210 has an outerdiameter that is greater than an inner diameter of at least a portion ofthe sleeve 220 such that the insert 210 will deformably expand thesleeve 220 upon insertion of the insert 210 therein. This will allow thesleeve 220 to be embedded within the bone tunnel, thereby anchoring thesuture anchor 220 in the bone tunnel. As further shown in FIG. 15, theinsert 210 can also have a flared proximal end 210 a that has anincreased outer diameter as compared to the remainder of the insert 210.The flared proximal end 210 a can be effective to expand the proximaltrailing end 220 a of the sleeve 220 to further facilitate engagementbetween the sleeve 220 and the bone tunnel within which the sleeve 220is disposed.

As further shown in FIGS. 15 and 16, the insert 210 can also be hollowto allow the inserter shaft 110 (FIG. 10) to extend therethrough and tomate with the sleeve 220, which in this embodiment is positioned distalof the insert 210. As indicated above, the insert 210 is also preferablyconfigured to mate to a suture for anchoring the suture to bone. Whilethe insert 210 can include various features for mating with a suture, inthe embodiment shown in FIGS. 15 and 16 the insert 210 includes firstand second thru-bores 214 a, 214 b formed therein and configured toreceive the suture therethrough. The use of two thru-bores 214 a, 214 bis advantageous as it allows the suture to extend into the firstthru-bore 214 a and out of the second thru-bore 214 b such that a sutureloop is formed and two trailing ends of the suture extend from theanchor 200.

As indicated above, in certain exemplary embodiments the insert 210 canbe configured to deformably and optionally irreversibly expand at leasta portion of the sleeve 220 into the bone tunnel. A person skilled inthe art will appreciate that various materials can be used to allow thesleeve 220 to expand. In one exemplary embodiment, however, the sleeve220 and the insert 210 can each be substantially rigid and they can havethe same modulus of elasticity.

The insert 210 and the sleeve 220 can also include various otherfeatures formed thereon. For example, the insert 210 and the sleeve 220can include an alignment mechanism formed there between and configuredto radially align the insert 210 with the sleeve 220. While variousalignment techniques can be used, as shown in FIGS. 13 and 14 theproximal-most end of the sleeve 220 includes a plurality of protrusions223 extending proximally therefrom. The protrusions 223 are configuredto sit within corresponding detents or bores 213 formed around a distalend of the insert 210, as shown in FIGS. 15 and 16.

In another embodiment, the insert 210 and the sleeve 220 can include anengagement mechanism formed there between for locking the insert 210 andthe outer sleeve 220 together to prevent accidental removal of theinsert 210 from the sleeve 2210 once the anchor 200 is implanted. Whilevarious engagement mechanisms can be used, including a friction,interference fit, mechanical interlock, etc., in one exemplaryembodiment the insert 210 and the sleeve 220 include a snap-lockengagement mechanism that utilizes at least one pin and at least onecomplementary bore for receiving the pin. As shown in FIGS. 15 and 16,the insert 210 includes a plurality of pins 217 formed thereon andspaced around a perimeter thereof. The pins 217 increases in height in adistal to proximal direction. When the insert 210 is positioned withinthe sleeve 220, the pins 217 will extend into corresponding bores 227formed in the sleeve 220 and spaced around a perimeter thereof, as shownin FIGS. 13 and 14. The increasing height of the pins 217 will allow thepins 217 to slide into the bores 227 during insertion of the insert 210into the sleeve 220, and will allow a trailing end or distal end of eachpin 217 to extend through and engage the bores 227 to prevent back-outor removal of the insert 210 from the sleeve 220. The insert 210 willthus snap-lock into the sleeve 220 to provide a secure mating connectionbetween the two components. The aforementioned alignment mechanismsformed between the insert 210 and the pusher 120, and between the insert210 and sleeve 220, will assist in aligning the pins 217 with the bores227 during use.

A person skilled in the art will appreciate that the suture anchor canhave a variety of other configurations, and that the suture anchordescribed and disclosed herein is merely one exemplary embodiment of asuture anchor for use with the present invention.

Referring back to FIG. 11, the suture anchor 200 is shown mated to theinsertion assembly 100. In particular, the inserter shaft 110 extendsthrough the insert 210 and is threadably mated to the sleeve 220 suchthat the distal-most tip 114 of the inserter shaft 110 extends throughthe opening 221 in the distal end 220 b of the sleeve 220. The insert210 is thus positioned just proximal of the sleeve 220 such that theleading distal end 210 b of the insert 210 is positioned adjacent to orin contact with the trailing proximal end 220 a of the sleeve 220. Theprotrusions on the proximal end of the sleeve 220 can seat within thedetents or bores formed around the distal end of the insert 210 toradially or rotationally align the insert 210 and the sleeve 220. Theproximal end 210 a of the insert 210 can be positioned adjacent to or incontact with the distal end 120 d of the pusher 120 such that thecut-out or notch in the proximal end of the insert 210 extends into andis aligned with the cut-out or notch in the distal end of the pusher120. FIG. 11 also illustrates a suture threaded through the first andsecond thru-bores to form a suture loop on one side of the anchor. Twotrailing ends 300 a, 300 b of the suture 300 extend proximally from thesuture anchor 200.

As shown in FIG. 17 and as previously described herein, the insertionassembly 100, with the suture anchor 200 mated thereto, can be mated toa deployment device, such as device 10, for deploying the suture anchor200 into bone. The trailing ends 300 a, 300 b of the suture 300 can bemated to the suture tensioning element 26 by winding the trailing ends300 a, 300 b around the tensioning wheel 27, and optionally rotating thetensioning wheel 27 to increase or decrease a tension applied to thesuture 300, as may be desired. The suture 300 thus remains taughtbetween the suture anchor 200 and the suture tensioning element 26.

The suture anchor 200 can be implanted by first passing the suturethrough the soft tissue to be anchored, and then mating the suture tothe suture anchor 200 and suture tensioning element 26. With the softtissue mated to the suture, the inserter shaft 110 can be forceddistally through into the bone, pulling the soft tissue toward the bone.It will be appreciated that, as this occurs, the suture anchor 200 willbe carried into the bone in its pre-deployed configuration, due to thethreaded engagement between the sleeve 220 and the inserter shaft 110.In fact, the distal end of the inserter shaft 110 and the tapered distalend of the sleeve 220 will cooperate with one another so as to force anopening in the bone, without any need for pre-drilling. The bone can,however, optionally be pre-drilled if desired, or a mallet or otherdevice can be used to facilitate insertion into bone.

Alternatively, the suture anchor 200 can be implanted by penetrating or“stabbing” the sharp distal end of the inserter shaft 110 into softtissue (or the like) to be anchored, and positioning it against bone towhich the soft tissue is to be anchored. The trailing ends 300 a, 300 bof the suture 300 will remain attached to the suture tensioning element26. The soft tissue may alternatively be gripped by another instrument(e.g., forceps or the like) and moved into position against the bonewhereby the inserter shaft 110 can be forced distally through the tissueand into the bone. Again, it will be appreciated that, as this occurs,suture anchor 200 will be carried into the bone in its pre-deployedconfiguration, due to the threaded engagement between the sleeve 220 andthe inserter shaft 110. In fact, the distal end of the inserter shaft110 and the tapered distal end of the sleeve 220 will cooperate with oneanother so as to force an opening in the soft tissue and the bone,without any need for pre-drilling. As indicated above, the bone can,however, optionally be pre-drilled if desired, or a mallet or otherdevice can be used to facilitate insertion into bone.

The inserter shaft 110 can be driven into the bone to various depths,but in an exemplary embodiment the inserter shaft 110 is driven intobone until the proximal trailing end of the insert 210 is approximatelyeven with the outer surface of the bone. More preferably, the insertershaft 110 can be driven deeper into bone, and the distal end 120 d ofthe pusher 120 can act as a stop shoulder that limits the penetrationdepth of the inserter shaft 110. In other embodiments, markings (notshown) may be placed on the outer surface of the inserter shaft 110 sothat proper depth penetration can be achieved.

Next, the trigger 34 on the deployment device 10 can be moved from theopen position, shown in FIG. 1, to the closed position, shown in FIG. 17by squeezing the trigger 34. As the trigger 34 pivots to the closedposition, the handle assembly 30 will slide proximally relative to thehousing 20, thus pulling the inserter shaft 110 proximally relative tothe outer shaft 22. The housing 20, outer shaft 22, pusher 120, andinsert 210 will remain in a substantially fixed position as the handleassembly 30, inserter shaft 110, and sleeve 220 move proximally. Thus,the suture 300 extending between the anchor 200 and the suturetensioning element 26 will remain fixed so as to not interfere with thetension applied to the suture 300. The tension thus remains unchanged.As the sleeve 220 is pulled proximally over the insert 210, theinterference fit between the sleeve 220 and the insert 210 will trap andlock the suture 300 there between, and the insert 210 will be lockedwithin the sleeve 220 using the snap-fit engagement previouslydiscussed. The insert 210 can also cause at least a portion of thesleeve 220 to expand, e.g., the proximal portion, causing the sleeve 220to engage the bone tunnel. Once fully deployed, the inserter shaft 110can be unscrewed from the sleeve 220 and removed, leaving the sutureanchor 200 behind. The trailing ends 300 a, 300 b of the suture 300 thatextend from the suture anchor 200 and through the soft tissue can beknotted, e.g., using a knotting element, or otherwise fastened to securethe soft tissue to the bone.

A person skilled in the art will appreciate that the insert canoptionally be advanced into the sleeve as the sleeve remains in asubstantially fixed position. The tension applied to the suture in suchcase will still remain fixed, as the suture and tensioning elementattached thereto will move with the insert. In other embodiments, thesleeve can be positioned proximal of the insert, and the insert can beretracted into the sleeve or the sleeve can be pushed over the insert.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is: 1-8. (canceled)
 9. A suture anchor assembly,comprising: a hollow insert having at least one bore formed therein andconfigured to receive a suture therethrough; an outer sleeve disposableover the insert and configured to lock a suture between the outer sleeveand the insert, wherein the insert and the outer sleeve include asnap-lock engagement mechanism formed there between for locking theinsert and the outer sleeve together; and an inserter shaft having adistal end extending through the insert and removably mated to the outersleeve.
 10. The suture anchor assembly of claim 9, wherein the insertershaft includes a pusher slidably disposed thereon and configured to abutagainst a proximal end of the insert to allow the pusher and insertershaft to be moved relative to one another to position the outer sleeveover the insert.
 11. The suture anchor assembly of claim 10, wherein theproximal end of the insert and a distal end of the pusher include analignment mechanism formed there between and configured to rotationallyalign the insert with the pusher.
 12. (canceled)
 13. The suture anchorassembly of claim 9, wherein the snap-lock engaging mechanism comprisesat least one pin formed on at least one of the insert and the outersleeve, and at least one complementary bore formed in the other one ofthe insert and the outer sleeve.
 14. The suture anchor assembly of claim9, wherein the trailing end of the insert is flared and is configured tofrictionally engage a trailing end of the outer sleeve. 15-22.(canceled)
 23. A suture anchor assembly, comprising: a hollow inserthaving at least one bore formed therein and configured to receive asuture therethrough; an outer sleeve disposable over the insert andconfigured to lock a suture between the outer sleeve and the insert: analignment mechanism formed between the insert and the outer sleeve andconfigured to rotationally align the insert and the outer sleeve duringinsertion of the outer sleeve over the insert; and an inserter shafthaving a distal end extending through the insert and removably mated tothe outer sleeve.